The following data is part of a premarket notification filed by Bridge To Life Ltd. with the FDA for Cannula For Organ Perfusion.
| Device ID | K203262 |
| 510k Number | K203262 |
| Device Name: | Cannula For Organ Perfusion |
| Classification | System, Perfusion, Kidney |
| Applicant | Bridge To Life Ltd. 128 Suber Rd., Suite A Columbia, SC 29210 |
| Contact | Brett Schultz |
| Correspondent | H Carl Jenkins Wood Burditt Group 10 E Scranton Ave, Ste 201 Lake Bluff, IL 60044 |
| Product Code | KDN |
| CFR Regulation Number | 876.5880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-11-05 |
| Decision Date | 2021-07-01 |